FDA+ channel feed – Endpoints News

FDA+ channel feed

Voyager shares take a hit as FDA slaps a hold on the IND for Huntington's gene therapy — their #2 play in the pipeline

5 years ago

Alkermes likely headed for approval after adcomm waves through schizophrenia and bipolar program

5 years ago

FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price

5 years ago

The ousted spokesperson that Stephen Hahn removed? FDA says she’s still an appointee, but won’t say what she does

5 years ago

In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder

5 years ago

FDA documents raise opioid abuse potential but pave a path toward badly-needed approval for Alkermes

5 years ago

Facing broad pushback from industry, White House backs down on FDA's Covid-19 vaccine guidance

5 years ago

No new guidance, but here's some advice: FDA draws a line in the sand for Covid-19 vaccine developers

5 years ago

Trump officials said industry didn't want FDA's stricter vaccine guidance, but the leading developer says they never discussed it

5 years ago

FDA hands Y-mAbs refusal to file letter in one of its pediatric neuroblastoma programs

5 years ago

CDER asks FDA to revoke Makena's accelerated approval less than a week after AMAG acquisition

5 years ago

After weathering failure, rejection and layoffs, ImmunoGen touts a new 'breakthrough' drug in its comeback plan

5 years ago

The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy

5 years ago

FDA gives thumbs down for Mesoblast's aGVHD drug, saying one single-arm trial is not enough

5 years ago

Mesoblast asks for trading halt as PDUFA date slides by. What's up?

5 years ago

Solid gets another shot in DMD gene therapy race as FDA lifts hold. But is it too late to catch Pfizer, Sarepta?

5 years ago

Hahn insists FDA will stick to guidelines for Covid-19 vaccine decisions

5 years ago

District Court throws out Catalyst lawsuit alleging improper approval standards for rival LEMS drug

5 years ago

Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review

5 years ago

Slammed by FDA rejection, Aquestive vows to refile by end of year

5 years ago

One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia

5 years ago

Covid-fattened shares crash as FDA puts a late-stage coronavirus vaccine trial on hold

5 years ago

FDA coffers are tapped for a down payment on a $300M Covid-19 PSA to ‘defeat despair’

5 years ago

Gilead wins a blockbuster consolation prize with EC, Japanese approvals for filgotinib — but that barely softens the blow of the FDA's CRL

5 years ago

First page Previous page 122 123 124125126 127 128 Next page Last page